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Medical Device Cybersecurity: Following New FDA Guidance
- Cybersecurity plan
- Risk-based analysis
- Hazard analysis following ISO 14971
- Risk communication to users
- Required membership in information sharing groups
- Reporting requirements and the exceptions
Overview of the webinar
The company must establish a program where they identify, analyze and control cybersecurity risks. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to device users. A complex set of reporting requirements have been established with some exceptions.
This webinar will describe a program that will be compliant with the FDA requirements.
Who should attend?
- Development Engineers
- Production Management
- QA/QC Personnel
- Software Developers
- IT Personnel
Why should you attend?
Medical device cybersecurity has become very important to the FDA. They have issued two recent guidances on the subject; the latest in December of 2016. FDA expects a proactive extensive risk-based program to minimize risk to the user from cyber attacks including involvement with information sharing groups.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.